Leveraging multi-biomarkers for precision diagnosis of coronary heart disease with phlegm and blood stasis syndrome: a real-world observational study protocol

Objective: To assess the diagnostic value of multiple biomarkers, including blood lipid, coagulation, and inflammatory markers, both individually and in combination, for assisting the precision diagnosis of coronary heart disease with phlegm and blood stasis syndrome (CHD-PBSS) in a real-world observational study, thereby providing a scientific basis for future research on the precision diagnosis of CHD-PBSS. Methods: This is a multi-center, real-world observational study designed to recruit 360 patients aged 35–70 years with chronic stable CHD from several medical institutions, including Beijing First Hospital of Integrated Chinese and Western Medicine, Yichang Hospital of Traditional Chinese Medicine (TCM), and Huanggang Hospital of TCM. Patients with CHD-PBSS were assigned to the PBSS group ( n = 180), whereas those with CHD but without PBSS (CHD-NPBSS) were assigned to the NPBSS group ( n = 180). We compared the levels of blood lipid, coagulation, and inflammatory biomarkers between the two groups and subsequently evaluated the diagnostic accuracy of these biomarkers, both individually and in combination, for identifying PBSS in patients with CHD. Discussion: The precision diagnosis of PBSS, a critical syndrome in CHD, is crucial for developing effective prevention and management strategies within the framework of TCM. This study aims to identify clinical diagnostic biomarkers of CHD-PBSS through real-world clinical trials, providing a theoretical basis for achieving accurate TCM syndrome diagnosis . However, the observational design has inherent limitations, as it only offers basic demographic information and does not allow for causal inference. In addition, the complexity of TCM syndromes and the subjectivity of clinicians’ judgements may introduce information and selection biases, potentially affecting the accuracy of the results.